Background Aortic stenosis-related mortality might vary across demographic subsets, regions, and states in the United States. Methods and Results We reviewed the death certificate data from the Centers for Disease Control and Prevention Wide-Ranging OnLine Data for Epidemiologic Research database to examine aortic stenosis-related mortality trends from 2008 to 2018. Crude and age-adjusted mortality rates (AAMRs) per 100 000 people and annual percentage change with 95% CIs were calculated. Between 2008 and 2018, AAMR reduced from 12.7 to 11.5 (average annual percentage change, -1.0 [95% CI, -1.5 to -0.5]), because of an accelerated decline between 2015 and 2018 (annual percentage change, -4.4 [95% CI, -6.0 to -2.7]). Older (aged >85 years), male, and White patients had higher death rates than younger, female, and non-White patients, respectively. Although mortality reduction was similar across sexes, significant mortality reduction was limited to White patients only. The AAMRs were higher in rural than urban areas. States with AAMRs >90th percentile were distributed in the West and the Northeast, and <10th percentile in the South. The AAMRs for sex and race were highest in the West and lowest in the South. None of the states located in the Midwest showed a significant reduction in mortality. Mortality remained stable for hospital setting and nursing home/long-term care facility, except that the number of deaths increased at home and hospice facility since 2014. Conclusions The reduction in mortality in patients with aortic stenosis was not consistent among demographic subsets and states. The substantial public health and economic implications call for determination of underlying clinical and socioeconomic factors to narrow the gap.
OBJECTIVE: Certain antihyperglycemic therapies modify cardiovascular and kidney outcomes among patients with type 2 diabetes, but early uptake in practice appears restricted to particular demographics. We examine the association of Medicaid expansion with use of and expenditures related to antihyperglycemic therapies among Medicaid beneficiaries. RESEARCH DESIGN AND METHODS: We employed a difference-in-difference design to analyze the association of Medicaid expansion on prescription of noninsulin antihyperglycemic therapies. We used 2012-2017 national and state Medicaid data to compare prescription claims and costs between states that did (n = 25) and did not expand (n = 26) Medicaid by January 2014. RESULTS: Following Medicaid expansion in 2014, average noninsulin antihyperglycemic therapies per state/1,000 enrollees increased by 4.2%/quarter in expansion states and 1.6%/quarter in nonexpansion states. For sodium-glucose cotransporter 2 inhibitors (SGLT2i) and glucagon-like peptide 1 receptor agonists (GLP-1RA), quarterly growth rates per 1,000 enrollees were 125.3% and 20.7% for expansion states and 87.6% and 16.0% for nonexpansion states, respectively. Expansion states had faster utilization of SGLT2i and GLP-1RA than nonexpansion states. Difference-in-difference estimates for change in volume of prescriptions after Medicaid expansion between expansion versus nonexpansion states was 1.68 (95% CI 1.09-2.26; P < 0.001) for all noninsulin therapies, 0.125 (-0.003 to 0.25; P = 0.056) for SGLT2i, and 0.12 (0.055-0.18; P < 0.001) for GLP-1RA. CONCLUSIONS: Use of noninsulin antihyperglycemic therapies, including SGLT2i and GLP-1RA, increased among low-income adults in both Medicaid expansion and nonexpansion states, with a significantly greater increase in overall use and in GLP-1RA use in expansion states. Future evaluation of the population-level health impact of expanded access to these therapies is needed.
BACKGROUND: Although chronic lung disease is a common cause of mortality, little is known about where individuals with chronic lung disease die. RESEARCH QUESTION: The aim of this study was to determine the trends and factors associated with place of death among individuals with chronic lung disease. STUDY DESIGN AND METHODS: This cross-sectional analysis of natural deaths was conducted by using the Centers for Disease Control and Prevention Wide-ranging OnLine Data for Epidemiologic Research from 2003 to 2017 for which COPD, interstitial lung disease (ILD), or cystic fibrosis (CF) was the underlying cause. Place of death was categorized as hospital, home, nursing facility, hospice facility, and other. RESULTS: From 2003 to 2017, more than 2.2. million deaths were primarily attributed to chronic lung disease (51.6% female, 92.4% white). Most were attributed to COPD (88.9%), followed by ILD (10.8.%), and CF (0.3%). Hospital and nursing facility deaths declined from 44.4% (n = 59,470) and 22.6% (n = 30,285) to 28.3% (n = 49,655) and 19.7% (n = 34,495), while home and hospice facility deaths increased from 23.3% (n = 31,296) and 0.1% (n = 192) to 34.7% (n = 60,851) and 9.0% (n = 15,861), respectively. Male sex, being married, and having some college education were associated with increased odds of home death, whereas non-white race and Hispanic ethnicity were associated with increased odds of hospital death. Compared with individuals with COPD, individuals with ILD and CF had increased odds of hospital death and reduced odds of home, nursing facility, or hospice facility death. INTERPRETATION: Home deaths are rising among decedents from chronic lung disease, increasing the need for quality end-of-life care in this setting. Further research should explore the end-of-life needs and preferences of these patients and their caregivers, with particular attention paid to patients with ILD and CF who continue to have high rates of hospital death.
Importance: Multiple analyses in a clinical trial can increase the probability of inaccurately concluding that there is a statistically significant treatment effect. However, to date, it is unknown how many randomized clinical trials (RCTs) perform adjustments for multiple comparisons, the lack of which could lead to erroneous findings. Objectives: To assess the prevalence of multiplicity and whether appropriate multiplicity adjustments were performed among cardiovascular RCTs published in 6 medical journals with a high impact factor. Design, Setting, and Participants: In this cross-sectional study, cardiovascular RCTs were selected from all over the world, characterized as North America, Western Europe, multiregional, and rest of the world. Data were collected from past issues of 3 cardiovascular journals (Circulation, European Heart Journal, and Journal of the American College of Cardiology) and 3 general medicine journals (JAMA, The Lancet, and The New England Journal of Medicine) with high impact factors published between August 1, 2015, and July 31, 2018. Supplements and trial protocols of each of the included RCTs were also searched for multiplicity. Data were analyzed December 20 to 27, 2018. Exposures: Data from the selected RCTs were extracted and verified independently by 2 researchers using a structured data instrument. In case of disagreement, a third reviewer helped to achieve consensus. An RCT was considered to have multiple treatment groups if it had more than 2 arms; multiple outcomes were defined as having more than 1 primary outcome, and multiple analyses were defined as analysis of the same outcome variable in multiple ways. Multiplicity was examined only for the analysis of the primary end point. Main Outcomes and Measures: Outcomes of interest were percentages of primary analyses that performed multiplicity adjustment of primary end points. Results: Of 511 cardiovascular RCTs included in this analysis, 300 (58.7%) had some form of multiplicity; of these 300, only 85 (28.3%) adjusted for multiplicity. Intervention type and funding source had no statistically significant association with the reporting of multiplicity risk adjustment. Trials that assessed mortality vs nonmortality outcomes were more likely to contain a multiplicity risk in their primary analysis (66.3% [177 of 267] vs 50.4% [123 of 244]; P < .001), and larger trials vs smaller trials were less likely to make any adjustments for multiplicity (35.6% [52 of 146] vs 21.4% [33 of 154]; P = .001). Conclusions and Relevance: Findings from this study suggest that cardiovascular RCTs published in medical journals with high impact factors demonstrate infrequent adjustments to correct for multiple comparisons in the primary end point. These parameters may be improved by more standardized reporting.
Heart failure (HF) is a progressive condition with high mortality and heavy symptom burden. Despite guideline recommendations, cardiologists refer to palliative care at rates much lower than other specialties and very late in the course of the disease, often in the final 3 days of life. One reason for delayed referral is that prognostication is challenging in patients with HF, making it unclear when and how the limited resources of specialist palliative care will be most beneficial. It might be more prudent to consider palliative care referrals at critical moments in the trajectory of patients with HF. These include: a) the development of poor prognostic signs in the outpatient setting; b) hospitalization or intensive care unit admission, and c) at the time of evaluation for certain procedures, such as left ventricular assist device placement and ablation for refractory ventricular arrhythmias, among others. In this review, we also summarize the results of clinical trials evaluating palliative interventions in these settings.
Background In 1993, the US Food and Drug Administration established guidelines to increase diversity by sex and race/ethnicity of participants in clinical trials supporting novel drug approvals. In this study we investigated the 10-year trends of participation of women and minorities in pivotal trials supporting approval of new molecular entities in cardiometabolic drugs from January 2008 to December 2017. Methods and Results A list of new molecular entities was abstracted from publicly available data at Drugs@Fda. Sex and race/ethnicity data were collected from trial publications. Linear regression analysis was performed to assess the relation between drug approval year and proportion of women and minorities enrolled. Thirty-five novel cardiovascular (n=24) and diabetes mellitus (n=11) drugs were approved by the US Food and Drug Administration during the study period. The median number of participants supporting each drug was 5930 (interquartile range, 3175-10 942). Women represented 36% (n=108 052) of trial participants (n=296 163). Women were underrepresented compared with their proportion of the disease population in trials of coronary heart disease (participation-to-prevalence ratio, 0.52), heart failure (participation-to-prevalence ratio, 0.58), and acute coronary syndrome (participation-to-prevalence ratio, 0.68). Among trial participants, 81% were white, 4% black, 12% Asian, and 11% Hispanic/Latino. There was no significant association between enrollment of women (P=0.29) or underrepresented minorities (P=0.45) with the drug approval year. Conclusions Over the past decade (2008-2017), women and minorities, particularly blacks, have continued to be inadequately represented in pivotal cardiometabolic clinical trials that support US Food and Drug Administration approval of new molecular entities. This may have major implications in determining efficacy of such therapies in these groups, and may impair generalizability of trial results to routine clinical practice.
OBJECTIVES: To assess trends and factors associated with place of death among individuals with Alzheimer's disease-related dementias (ADRD). DESIGN: Cross-sectional analysis. SETTING: Centers for Disease Control and Prevention Wide-ranging OnLine Data for Epidemiologic Research, 2003-2017. PARTICIPANTS: Natural deaths occurring between 2003 and 2017 for which ADRD was determined to be the underlying cause. MEASUREMENTS: Place of death was categorized as hospital, home, nursing facility, hospice facility, and other. Aggregate data included age, race, Hispanic ethnicity, sex, urbanization, and census division. Individual-level predictors included age, race, Hispanic ethnicity, sex, marital status, and education. RESULTS: From 2003 to 2017, nursing facility and hospital deaths declined from 65.7% and 12.7% to 55.0% and 8.0% while home and hospice facility deaths increased from 13.6% and .2% to 21.9% and 6.2%, respectively. Odds of hospital and hospice facility deaths declined with age while odds of nursing facility deaths increased with age. Male sex was associated with higher odds of hospital or hospice facility death and lower odds of home or nursing facility death. Nonwhite race, Hispanic ethnicity, and being married were associated with increased odds of hospital or home death and reduced odds of nursing facility death. More education was associated with higher odds of home or in a hospice facility death and reduced odds of death in a nursing facility or hospital. Significant disparities in place of death by urban-rural status were also noted. CONCLUSION: As ADRD deaths at home increase, the need for caregiver support and home-based palliative care may become more critical. Further research should examine the care preferences and experiences of ADRD patients and caregivers, the financial impact of home death on families and insurers, and explore factors that may contribute to differences in actual and preferred place of death. J Am Geriatr Soc 68:250-255, 2020.
BACKGROUND: The location of death is an important component of end-of-life care. However, contemporary trends in the location of death for cardiovascular deaths related to heart failure (CV-HF) and comparison to cancer deaths have not been fully examined. METHODS: We analyzed data from the Centers for Disease Control and Prevention's Control Wide-Ranging Online Data for Epidemiologic Research database between 2003 and 2017 to identify location of death for CV-HF and cancer deaths. The proportions of deaths that occurred in a hospice facility, home, and medical facility were tested for trends using linear regression. Odds ratios were calculated to determine the odds of death occurring in a hospice facility or home (versus a medical facility) stratified by sex and race. RESULTS: We identified 2 940 920 CV-HF and 8 852 066 cancer deaths. Increases were noted in the proportion of CV-HF deaths in hospice facilities (0.2% to 8.2%; Ptrend<0.001) and at home (20.6% to 30.7%; Ptrend<0.001), whereas decreases were noted in the proportion of deaths in medical facilities (44.5% to 31.0%; Ptrend<0.001) and nursing homes (30.8% to 25.7%; Ptrend<0.001). The odds of dying in a hospice facility (odds ratio, 1.79 [1.75-1.82]) or at home (odds ratio, 1.55 [1.53-1.56]) versus a medical facility was higher for whites versus blacks. The rate of increase in proportion of deaths in hospice facilities was higher for cancer deaths (beta=1.05 [95% CI, 0.97-1.12]) than for CV-HF deaths (beta=0.61 [95% CI, 0.58-0.64]). CONCLUSIONS: The proportion of CV-HF deaths occurring in hospice facilities is increasing but remains low. Disparities are noted whereby whites are more likely to die in hospice facilities or at home versus medical facilities compared with blacks. More research is needed to determine end-of-life preferences for patients with HF and identify the basis for these differences in location of death.